Benzinga | Jun 22, 2021 07:17AM EDT

Fennec Pharma Stock Is Trading Higher As Pedmark Is Under FDA Review For Chemo-Induced Toxicity

* The FDA has accepted for review Fennec Pharmaceuticals Inc's (NASDAQ:FENC) resubmitted marketing application seeking approval for Pedmark (formulated sodium thiosulfate) to prevent ototoxicity induced by cisplatin chemotherapy.

* The application covers patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

* The agency's target action date is set for November 27.

* If approved, Pedmark stands to be the first FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients, the company said.

* The FDA has granted Pedmark both Fast Track Designation and Breakthrough Therapy Designation.

* The Complete Response Letter received in August 2020 referred to deficiencies with the facility of the drug product manufacturer.

* No clinical safety or efficacy issues were identified, and there was no requirement for further clinical data.

* Price Action: FENC shares are up 4.83% at $6.95 during the premarket trading session on the last check Tuesday.